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Trial registered on ANZCTR

Registration number

ACTRN12624000984594p

Ethics application status

Submitted, not yet approved

Date submitted

25/07/2024

Date registered

13/08/2024

Date last updated

28/10/2024

Date data sharing statement initially provided

13/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

A study testing a new pharmacist-led service to improve medicine use in older adults.

Scientific title

A cluster randomised controlled trial to evaluate a pharmacist-led intervention addressing inappropriate polypharmacy and its impact on medication use outcomes in older adults

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1300-9210

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Problematic polypharmacy

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participating general practice clinics will be selected as the unit for allocation. Patient participants from general practice clinics assigned to the intervention group will receive the PolyCare intervention, which aims to improve medicine use and reduce inappropriate prescribing in older adults with polypharmacy.

The stages of the PolyCare intervention include:
1) Utilising PolyScan, a novel information technology tool to identify eligible patients aged 65 years or older, prescribed five or more medicines, and with potentially inappropriate medicines (PIMs).
PolyScan was developed based on 21 indicators from a New Zealand criteria of PIMs to correct for older adults with polypharmacy, which was programed into a set of implementable definitions. The tool is automatically linked to New Zealand hospital, emergency department, and pharmaceutical collection databases to classify whether each indicator is present at an individual patient level, and then triage individuals based on the number of indicators met [1]. Clinics and clinical pharmacists will access the PolyScan report electronically using their unique password encryption.

2) Enlisting clinical pharmacists to provide educational outreach to general practice clinics. A clinical pharmacist will meet with general practice clinicians as a group to:
- Review and discuss the findings from the PolyScan report.
- Discuss strategies to reduce problematic polypharmacy, advocating for rational and environmentally conscious prescribing.
- Detail the pharmacist's role in providing medicine reviews for clinic patients over the four-week intervention period.
- Request a clinic team member to facilitate the pharmacist's integration into the team and assist in resolving encountered difficulties.
Educational outreach (education package) will be conducted one month prior to conducting the first medicine review for patient participants (see step 3).

3) Enlisting clinical pharmacists to conduct medicine reviews for patient participants in collaboration with doctors and nurses.
Patient participants will be provided a one off, individualised, 60-minute, free appointment with a pharmacist to review their medicines. The medicine review will be conducted face-to-face, either at the patient's general practice clinic or in their home. The procedures for the medicine review are detailed below:
- Meeting with the patient to discuss their health and medicine background.
- Evaluating patient characteristics such as literacy level which may affect their health or medicine outcomes.
- Evaluating whether any patient symptoms could be attributed to the adverse effects or interactions from their medicines.
- Interpreting, assessing and monitoring patient laboratory results.
- Assessing, detecting, and prioritising patient medicine concerns including inappropriate polypharmacy, inappropriate medicines, dosage or regimens, adverse effects, contraindications, or interactions.
- Working with the patient to develop a mutually agreed plan to resolve identified medicine issues.
- Providing patients with medicine education and training.
- Communicating recommendations to the patient's general practitioner/nurse practitioner (GP/NP) and other clinicians through messages in the clinic's electronic patient management system.
The doctor/nurse will make the final decision regarding the pharmacist’s recommendations.

4) Monitoring and following up with patient participants post-medicine review.
Clinical pharmacists will monitor and follow-up with patient participants at 3-months and 6-months following the medicine review.

Clinical pharmacists delivering the PolyCare intervention must hold a current New Zealand annual practicing certificate and have experience practicing within general practice clinics.

A package has been developed to support clinical pharmacists to deliver the study. This package includes materials such as terms of reference, goals and objectives, role descriptions and purposes, contribution descriptions and responsibilities, boundaries, timelines, leadership structure, decision-making policy and authority, communication channels, the implementation framework, policy guidelines, patient eligibility criteria, patient information sheet/brochure, consent form, workflow and care pathway considerations, suggested solutions to potential implementation barriers, as well as resources such as Grimes and Barnett et al.'s patient-centered consultation skills program for pharmacy practice [2], and Lacey et al.'s 'Hui Process' framework for patient consultations [3].

The research team will develop a compulsory online training programme for all pharmacists to complete before delivering the study. The training programme will include multiple choice, matching, and true or false self-check questions, which provide small summative self-evaluations at the end of each topic section. After the training, an assessment comprising multiple choice, matching, true or false, and short answer questions will be used test competency. Each pharmacist would be required to complete the training and achieve a set passing grade in the assessment before delivering the study. Lastly, an evaluation form based on Sadler et al.’s research is included for pharmacists to evaluate the training using a five-point Likert scale [4]. An estimated six hours will be required to complete the online training.

Regarding intervention adherence, the clinical pharmacist delivering the intervention will inform the research team any patient participants that do not complete the medicine review in it's entirety.

Reference
1. Liu L, Alate R, Harrison J. Development and validation of PolyScan, an information technology triage tool for older adults with polypharmacy: a healthcare informatics study. J Prim Health Care. 2023;15(3):215-223.
2. Grimes L, Barnett N. Consultation skills for pharmacy practice: taking a patient-centred approach. Manchester: Centre for Pharmacy Postgraduate Education. 2014.
3. Lacey C, Huria T, Beckert L, et al. The Hui process: a framework to enhance the doctor-patient relationship with Maori. N Z Med J. 2011;124(1347):72–78.
4. Sadler S, Rodgers S, Howard R, et al. Training pharmacists to deliver a complex information technology intervention (PINCER) using the principles of educational outreach and root cause analysis. Int J Pharm Pract. 2014;22(1):47-58.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The patient participants from clinics assigned to the control group will receive usual clinic care. Usual care may include general practice services such as preventive care, diagnostic evaluations, the management of chronic conditions, and other standard primary care services. However, usual care will exclude pharmacist-led educational outreach and medicine review offered by the PolyCare intervention.

Following completion of the study, the researchers will offer support to control group patients and clinics. Control group clinics will be provided with a PolyScan report, which identifies the patients who have received PIMs for follow-up and review. Additionally, an accompanying research paper by Liu and Harrison will be provided, which explains the significance of each PIM for older adults with polypharmacy [1]. Disseminating this information will be passed to the practice manager or another delegate.

Reference
1. Liu L, Harrison J. Development of explicit criteria identifying potentially inappropriate polypharmacy in older adults in New Zealand primary care: a mixed-methods study. J Prim Health Care. 2023;15(1):38-47.

Control group

Active

Outcomes

Primary outcome [1]

The study will focus on a set of 21 PIM indicators from the New Zealand Criteria, which New Zealand expert clinicians have recognised as crucial to correct for older adults with polypharmacy [1].

The primary outcome will assess the change in the mean number of PIM indicators per patient participant, as identified in the New Zealand Criteria.

Reference:
1. Liu L, Harrison J. Development of explicit criteria identifying potentially inappropriate polypharmacy in older adults in New Zealand primary care: a mixed-methods study. JPHC. 2023; doi:10.1071/HC22135

Timepoint [1]

Data collection time-points will be at study baseline (primary time-point), three months, and six months after the intervention period.

Secondary outcome [1]

Patient-reported outcome measure.

Timepoint [1]

Data collection time-points will be at baseline, three months, and six months after the intervention period.

Secondary outcome [2]

Economic evaluation.

Timepoint [2]

Data collection time-point will be six months after the intervention period.

Secondary outcome [3]

Process evaluation.

Assessment method [3]

A mixed-methods process evaluation will assess the perspectives of pharmacists and GP/NPs towards PolyCare. All feedback will be assessed as a composite secondary outcome.

The researchers will collect quantitative data using:
- Study data collection forms to record patient demographic information, as well as the frequency and time pharmacists spent delivering each intervention activity. Completed data collection forms will be entered into a Microsoft Excel spreadsheet to summarise results [1].
- A training evaluation form for pharmacists to provide feedback on the online training program. Likert scale ratings will be calculated and presented in summary tables.
- A pharmacist assessment following the online training to evaluate competency to deliver the intervention. Marks from the competency assessment will be entered into a Microsoft Excel spreadsheet to summarise results [1].
- Intervention group pharmacists will receive an email invitation to complete the Professional Collaborative Practice Tool in REDCap anonymously [2]. The Professional Collaborative Practice Tool is a validated 14-item questionnaire measuring the perceived collaboration level between pharmacists and physicians [3]. Pharmacists will select from a Likert scale to indicate their perception of each item. The cumulative score is then calculated to assess the level of collaboration [3].

The researchers will collect qualitative data by conducting semi-structured interviews. The research team will randomly contact and invite intervention group GP/NPs and pharmacists until a sample of 30 participants (comprising 15 GP/NPs and 15 pharmacists) is achieved. The available study resources, time constraints, and the need to represent a variety of perspectives determined the proposed sample size. The research team will develop separate interview guides for GP/NP and pharmacist participants based on research from Bond et al. [4].
Interview topics will include:
- Pharmacist feedback regarding the training package.
- GP/NP and pharmacist feedback regarding the PolyScan tool.
- GP/NP and pharmacist feedback regarding the pharmacist-led educational outreach.
- GP/NP and pharmacist feedback regarding the pharmacist-led medication review and follow-up.
- GP/NP and pharmacist feedback regarding collaboration.
- GP/NP and pharmacist feedback regarding the barriers to delivering the intervention.
- GP/NP and pharmacist feedback regarding the facilitators of the intervention.
- GP/NP feedback regarding their opinion of pharmacist competency.
Interviews will be conducted in person, using a video-assisted platform, or through telephone, depending on participant preference. Interviews will be audio-recorded and transcribed by the researchers for analysis. A template analysis approach will be used to code interviews [5].

Using a triangulation approach, quantitative and qualitative data will be combined to determine consensus, partial consensus, or disagreement across the findings.

References
1. Microsoft. Excel [computer program]. Version 1808. Redmond, WA: Microsoft Corporation; 2021
2. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
3. Sanchez-Molina AI, Benrimoj SI, Ferri-Garcia R, et al. Development and validation of a tool to measure collaborative practice between community pharmacists and physicians from the perspective of community pharmacists: the professional collaborative practice tool. BMC Health Serv Res. 2022;22(1):649.
4. Bond CM, Holland R, Alldred DP, et al. Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study. Trials. 2020;21(1):439.
5. University of Huddersfield. What is Template Analysis? [Internet]. United Kingdom: University of Huddersfield; 2024 [cited 2024 Apr 14]. Available from: https://research.hud.ac.uk/research-subjects/human-health/template-analysis/what-is-template-analysis/

Timepoint [3]

Data collection time-points will be at baseline, three months, and six months after the intervention period.

Secondary outcome [4]

Environmental impact evaluation

Timepoint [4]

Data collection time-point will be at six months after the intervention period.

Secondary outcome [5]

Patient-reported outcome measure.

Timepoint [5]

Data collection time-points will be at baseline, three months, and six months after the intervention period.

Eligibility

Key inclusion criteria

Patients can qualify to take part in the study if they meet the following criteria:
- They are 65 years of age or older.
- Their current daily medicine regimen includes five or more medicines.
- They are presently prescribed one or more PIM indicators, as identified by the PolyScan tool.
- They can provide written informed consent, either by the patient or their welfare guardian/enduring power of attorney.
- They are registered at a general practice clinic that is participating in the study.

Pharmacists can qualify to take part in the study if they meet the following criteria:
- They possess a current Annual Practising Certification from the Pharmacy Council of New Zealand.
- They possess at least one year experience practising within general practice clinics.

GPs and NPs can qualify to take part in the study if they meet the following criteria:
- They are based in New Zealand.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Patients will be excluded if:
- They underwent a pharmacist-led medicine review within the last six months.
- They are unable to meet the requirements of the inclusion criteria.

Pharmacists, NPs/GPs will be excluded if:
- They are unable to meet the requirements of the inclusion criteria.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Procedure for enrolling patient participants:

The research team will meet with clinics to introduce the study. For those interested, consent will be requested from the chief executive officer or designated representative and indicated by signing a consent form.

For each clinic, the PolyScan IT tool will be used to identify older adults with polypharmacy who have been prescribed a PIM. A clinic staff member will be delegated to screen these patients against the eligibility criteria and contact eligible patients to introduce the study. Eligible patients interested in participating will be referred to the study pharmacist. The pharmacist will discuss the study with patients, and provide them with a participant information sheet and consent form to sign and return before recruitment.

Clinics will be selected as the unit for allocation. After clinics and patients have been recruited into the study, the researchers will stratify participating clinics based on the size of their enrolled population into three groups: 1) less than 5,000 patients, 2) between 5,000 and 10,000 patients, and 3) more than 10,000 patients. For each group, an "off-site" independent statistician, who has no interaction with clinics, will generate the randomisation sequence using a computerised randomisation table, and allocate clinics to the intervention or control group.

Allocation is concealed as it cannot be known which group a clinic is allocated to during recruitment, as allocation will only occur after clinics and patients have been recruited into the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participating general practice clinics will be stratified according to their number of enrolled patients, dividing them into three groups: 1) fewer than 5,000 patients, 2) between 5,000 and 10,000 patients, and 3) exceeding 10,000 patients.

For each strata, an independent statistician will be tasked with generating an allocation sequence using a randomisation table created by computer software. Sequence generation will involve labeling each clinic cluster, using computer software to generate a randomisation sequence, creating the randomisation table, and assigning each cluster to a treatment group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2025

Actual

Date of last participant enrolment

Anticipated

29/07/2025

Actual

Date of last data collection

Anticipated

29/01/2026

Actual

Sample size

Target

256

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

8 Grafton Road, Auckland Central, 1010, Auckland

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Lisheng Liu - University of Auckland

Address

The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Jeff Harrison - University of Auckland

Address [1]

The University of Auckland Faculty of Medical and Health Sciences. M&HS Building 505 - Bldg 505, 85 Park Road, Grafton, Auckland, 1023

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Trudi Aspden - University of Auckland

Address [2]

The University of Auckland Faculty of Medical and Health Sciences. M&HS Building 505 - Bldg 505, 85 Park Road, Grafton, Auckland, 1023

Country [2]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

New Zealand Health and Disability Ethics Committees

Ethics committee address [1]

133 Molesworth Street, Thorndon, Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/09/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Older adults often take more medicines, increasing the risk of unsafe medicine use that can lead to poor outcomes such as side effects and hospitalisation.

Clinical pharmacists are medicine experts who collaborate with doctors, nurses, and other healthcare professionals to ensure the safety and appropriateness of the medicines that people are taking.

A new service named PolyCare has been developed, which utilises clinical pharmacists to support doctors and nurses in reducing unsafe medicine use for older adults who are taking multiple daily medicines.

The purpose of this study is to test whether implementing the PolyCare service in general practice can improve outcomes for older adults. The study hypothesises that PolyCare can effectively reduce harmful medicine use for older adults.

Trial website

Trial related presentations / publications

Public notes

Liu L, Harrison J. Development of explicit criteria identifying potentially inappropriate polypharmacy in older adults in New Zealand primary care: a mixed methods study. J Prim Health Care. 2023;15(1):38-47.

Liu L, Alate R, Harrison J. Development and validation of PolyScan, an information technology triage tool for older adults with polypharmacy: a healthcare informatics study. J Prim Health Care. 2023;15(3):215-223.

Liu L, Brokenshire B, Davies D, Harrison J. Preliminary feasibility assessment of a targeted, pharmacist-led intervention for older adults with polypharmacy: a mixed-methods study. Int J Clin Pharm. 2024; doi: https://doi.org/10.1007/s11096-024-01740-y

Contacts

Principal investigator

Name

Mr Lisheng Liu

Address

The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland

Country

New Zealand

Phone

+64 7 270 1871

Fax

[email protected]

Contact person for public queries

Name

Lisheng Liu

Address

The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland

Country

New Zealand

Phone

+64 7 270 1871

Fax

[email protected]

Contact person for scientific queries

Name

Lisheng Liu

Address

The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland

Country

New Zealand

Phone

+64 7 270 1871

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Study participants will give informed consent with the understanding that their individual participant-level data will not be publicly accessible.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24012	Informed consent form					386940-(Uploaded-01-07-2024-15-09-57)-participant-information-sheet-consent-form-template-v5.0april2023.doc

Results publications and other study-related documents

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No additional documents have been identified.

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